Continuous passive paracentesis versus large-volume paracentesis in the prevention and treatment of intra-abdominal hypertension in the critically ill cirrhotic patient with ascites (COPPTRIAHL)

Detalhes bibliográficos
Autor(a) principal: Pereira, Rui Antunes
Data de Publicação: 2023
Outros Autores: Virella, Daniel, Perdigoto, Rui, Marcelino, Paulo, Saliba, Faouzi, Germano, Nuno
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10362/157748
Resumo: Funding Information: The authors would like acknowledge and thank the nursing and medical staff at Unidade de Cuidados Intensivos Polivalente 7 (UCIP7), Hospital Curry Cabral, CHULC, for their substantial work and cooperation in this project, as well as Luís Horta, PhD, Ana Luisa Papoila, PhD, and Marta Alves, M.Sc., at the CHULC Research Center for their collaboration and support. Publisher Copyright: © 2023, BioMed Central Ltd., part of Springer Nature.
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spelling Continuous passive paracentesis versus large-volume paracentesis in the prevention and treatment of intra-abdominal hypertension in the critically ill cirrhotic patient with ascites (COPPTRIAHL)study protocol for a randomized controlled trialAbdominal compartment syndromeAbdominal perfusion pressureAcute kidney injuryMulti-organ failureOutcomeRandomized controlled trialRenal failureMedicine (miscellaneous)Pharmacology (medical)Funding Information: The authors would like acknowledge and thank the nursing and medical staff at Unidade de Cuidados Intensivos Polivalente 7 (UCIP7), Hospital Curry Cabral, CHULC, for their substantial work and cooperation in this project, as well as Luís Horta, PhD, Ana Luisa Papoila, PhD, and Marta Alves, M.Sc., at the CHULC Research Center for their collaboration and support. Publisher Copyright: © 2023, BioMed Central Ltd., part of Springer Nature.Background: Critically ill patients with cirrhosis and ascites are at high risk for intra-abdominal hypertension (IAH) which increases mortality. Clinical guidelines recommend maintaining intra-abdominal pressure (IAP) below 16 mmHg; nonetheless, more than three quarters of critically ill patients with cirrhosis develop IAH during their first week of ICU stay. Standard-of-care intermittent large-volume paracentesis (LVP) relieves abdominal wall tension, reduces IAP, optimizes abdominal perfusion pressure, and is associated with short-term improvement in renal and pulmonary dysfunction. However, there is no evidence of the superiority of different paracentesis strategies in the prevention and treatment of IAH in critically ill patients with cirrhosis. This trial aims to compare the outcomes of continuous passive paracentesis versus LVP in the prevention and treatment of IAH in patients with cirrhosis and ascites. Methods: An investigator-initiated, open label, randomized controlled trial, set in a general ICU specialized in liver disease, was initiated in August 2022, with an expected duration of 36 months. Seventy patients with cirrhosis and ascites will be randomly assigned, in a 1:1 ratio, to receive one of two methods of therapeutic paracentesis. A stratified randomization method, with maximum creatinine and IAP values as strata, will homogenize patient baseline characteristics before trial group allocation, within 24 h of admission. In the control group, LVP will be performed intermittently according to clinical practice, with a maximum duration of 8 h, while, in the intervention group, continuous passive paracentesis will drain ascitic fluid for up to 7 days. The primary endpoint is serum creatinine concentration, and secondary endpoints include IAP, measured creatinine clearance, daily urine output, stage 3 acute kidney injury and multiorgan dysfunction assessed at day 7 after enrollment, as well as 28-day mortality rate and renal replacement therapy-free days, and length-of-stay. Prespecified values will be used in case of renal replacement therapy or, beforehand ICU discharge, liver transplant and death. Safety analysis will include paracentesis-related complication rate and harm. Data will be analyzed with an intention-to-treat approach. Discussion: This is the first trial to compare the impact of different therapeutic paracentesis strategies on organ dysfunction and outcomes in the prevention and treatment of IAH in critically ill patients with cirrhosis and ascites. Trial registration: ClinicalTrials.gov NCT04322201 .NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)RUNPereira, Rui AntunesVirella, DanielPerdigoto, RuiMarcelino, PauloSaliba, FaouziGermano, Nuno2023-09-13T22:17:21Z2023-08-152023-08-15T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10362/157748eng1745-6215PURE: 70240685https://doi.org/10.1186/s13063-023-07541-4info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-03-11T05:40:02Zoai:run.unl.pt:10362/157748Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T03:56:50.920961Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Continuous passive paracentesis versus large-volume paracentesis in the prevention and treatment of intra-abdominal hypertension in the critically ill cirrhotic patient with ascites (COPPTRIAHL)
study protocol for a randomized controlled trial
title Continuous passive paracentesis versus large-volume paracentesis in the prevention and treatment of intra-abdominal hypertension in the critically ill cirrhotic patient with ascites (COPPTRIAHL)
spellingShingle Continuous passive paracentesis versus large-volume paracentesis in the prevention and treatment of intra-abdominal hypertension in the critically ill cirrhotic patient with ascites (COPPTRIAHL)
Pereira, Rui Antunes
Abdominal compartment syndrome
Abdominal perfusion pressure
Acute kidney injury
Multi-organ failure
Outcome
Randomized controlled trial
Renal failure
Medicine (miscellaneous)
Pharmacology (medical)
title_short Continuous passive paracentesis versus large-volume paracentesis in the prevention and treatment of intra-abdominal hypertension in the critically ill cirrhotic patient with ascites (COPPTRIAHL)
title_full Continuous passive paracentesis versus large-volume paracentesis in the prevention and treatment of intra-abdominal hypertension in the critically ill cirrhotic patient with ascites (COPPTRIAHL)
title_fullStr Continuous passive paracentesis versus large-volume paracentesis in the prevention and treatment of intra-abdominal hypertension in the critically ill cirrhotic patient with ascites (COPPTRIAHL)
title_full_unstemmed Continuous passive paracentesis versus large-volume paracentesis in the prevention and treatment of intra-abdominal hypertension in the critically ill cirrhotic patient with ascites (COPPTRIAHL)
title_sort Continuous passive paracentesis versus large-volume paracentesis in the prevention and treatment of intra-abdominal hypertension in the critically ill cirrhotic patient with ascites (COPPTRIAHL)
author Pereira, Rui Antunes
author_facet Pereira, Rui Antunes
Virella, Daniel
Perdigoto, Rui
Marcelino, Paulo
Saliba, Faouzi
Germano, Nuno
author_role author
author2 Virella, Daniel
Perdigoto, Rui
Marcelino, Paulo
Saliba, Faouzi
Germano, Nuno
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
RUN
dc.contributor.author.fl_str_mv Pereira, Rui Antunes
Virella, Daniel
Perdigoto, Rui
Marcelino, Paulo
Saliba, Faouzi
Germano, Nuno
dc.subject.por.fl_str_mv Abdominal compartment syndrome
Abdominal perfusion pressure
Acute kidney injury
Multi-organ failure
Outcome
Randomized controlled trial
Renal failure
Medicine (miscellaneous)
Pharmacology (medical)
topic Abdominal compartment syndrome
Abdominal perfusion pressure
Acute kidney injury
Multi-organ failure
Outcome
Randomized controlled trial
Renal failure
Medicine (miscellaneous)
Pharmacology (medical)
description Funding Information: The authors would like acknowledge and thank the nursing and medical staff at Unidade de Cuidados Intensivos Polivalente 7 (UCIP7), Hospital Curry Cabral, CHULC, for their substantial work and cooperation in this project, as well as Luís Horta, PhD, Ana Luisa Papoila, PhD, and Marta Alves, M.Sc., at the CHULC Research Center for their collaboration and support. Publisher Copyright: © 2023, BioMed Central Ltd., part of Springer Nature.
publishDate 2023
dc.date.none.fl_str_mv 2023-09-13T22:17:21Z
2023-08-15
2023-08-15T00:00:00Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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dc.identifier.uri.fl_str_mv http://hdl.handle.net/10362/157748
url http://hdl.handle.net/10362/157748
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 1745-6215
PURE: 70240685
https://doi.org/10.1186/s13063-023-07541-4
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eu_rights_str_mv openAccess
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dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
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